Medical Information Specialist

Customer Service German
May 25, 2020
General Accounting, Senior Analyst (Italian speaker)
May 26, 2020

Medical Information Specialist

  • Permanent
  • Cork
  • Posted 2 weeks ago

Purcelloleary are working with a Global company recruiting for  a Clinical Researcher Associate will ensure inspection readiness through a complete, accurate and readily available Trial Master File. Additional local responsibilities may be required as needed/appropriate for the local geography and/or to cover regional differences.

Clinical Researcher – Capabilities Responsibilities

  • Initiate investigator site activities, including collection and submission of regulatory documents, customization and negotiation of informed consent documents, serve as the point of contact for a site’s ERB and Competent Authority (CA)(where applicable), communicate and negotiate budgets with site personnel and internal teams, negotiate and obtain fully-executed contract, track and ensure site compliance to required training, and effectively drive timelines aligned with company priorities
  • Communicate directly with sites to enable start-up and maintain an active collaboration with sites during maintenance and close-out
  • Identify, communicate, and resolve issues
  • Ensure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems
  • Leverage previous site / review board engagements to efficiently drive new work
  • Populate internal systems to ensure accuracy of trial / site performance
  • Understand and comply with procurements, legal and financial requirements and procedures
  • Populate Trial Master Files and libraries for future reference
  • Provide feedback and shared learning for continuous improvement
  • Leverage trial prioritization
  • Anticipate and monitor dynamically changing priorities

Clinical Researcher – Basic Qualifications :

Bachelor’s degree preferably in a scientific or health related field, two years clinical research experience or relevant experience preferred
Understanding of the overall clinical development paradigm and the importance of efficient site initiation
Applied knowledge of project management processes and skills
Appreciation of / experience in compliance-driven environment
Ability to learn and comply with financial and legal guidelines and policies (budget and contract)
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Additional Skills/Preferences : Effective communication, negotiation, and problem solving skills
Self-management and organizational skills
Language capabilities in the followings (English, German, French, Spanish, Italian, Polish, Swedish, Danish, Finish, Czech, Hungarian, Romanian, Dutch, Portuguese, Flemish, Swiss German), Austrian German, Slovakian, Hebrew, Russian,Ukranian, and Turkish

Additional Information :

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